Medicament delivery device with usage monitoring

ABSTRACT

A medicament delivery device is presented having a housing that is arranged to accommodate a medicament container, a drive unit operably arranged to act on the medicament container upon activation, an activation mechanism operably arranged to be operated by a user, an activation preventing mechanism operably arranged to prevent the activation mechanism to be activated, an usage management module arranged to be operated by a user, which usage management module is designed as an attachable unit to the medicament delivery device. First keying elements are arranged on the device and on the usage management module designed to interact with each other when attaching said usage management module, such as to cause a deactivation of the activation preventing mechanism to allow operation of the activation mechanism. The usage management module can include a monitoring circuit arranged to monitor the use of the medicament delivery device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 15/544,083, filed Jul. 17, 2017, now U.S. Pat. No. 10,668,220, whichis a U.S. National Phase application pursuant to 35 U.S.C. § 371 ofInternational Application No. PCT/EP2016/051458 filed Jan. 25, 2016,which claims priority to Swedish Patent Application No. 1550144-8 filedFeb. 9, 2015. The entire disclosure contents of these applications areherewith incorporated by reference into the present application.

TECHNICAL AREA

The present disclosure relates to medicament delivery devices and inparticular medicament delivery devices provided with mechanisms relatedto specific approved users.

BACKGROUND

There is a constant development of medicament delivery devices that areintended and designed to be used and handled by users that are notqualified nursing staff or physicians, i.e. handled by the patientsthemselves. Because the patients themselves handle the treatment, basedon a specific treatment scheme, the physicians treating the patient haveno direct information that the treatment schemes are followed asprescribed.

In order to obtain more information regarding the treatment, a number ofdevices have been developed that are capable of monitoring the dosedelivery operations and to store this information. Some devices are alsocapable of transmitting the information to external storage locationsthat are accessible to a trained healthcare staff. This enables accessto relevant dose delivery information to e.g. a physician of a patient.

Document U.S. Pat. No. 8,361,026 discloses a medicament delivery devicethat is arranged with a number of intelligent functions that may monitorthe operation of the device. Among the functions are monitoring ofappliance and/or adherence of the patient and uploading of theinformation to a suitable storage means of a remote device, where thelatter could be a remote communication network, a computer, a smartphone, personal digital assistant, etc. Information could also bedownloaded to the medicament delivery device to be accessible to theuser, such as if the drug of a medicament in the device has beenrecalled by the manufacturer of the drug, that the drug has expired orupdated user information. In this regard, the device is arranged with anumber of switches that are activated during different functionalstages.

The device according to U.S. Pat. No. 8,361,026 is very complex and thuscostly. It would be an advantage if monitoring functionality could beprovided also to simpler medicament delivery devices such as those thatare disposed of after use. Regarding monitoring of adherence, it wouldalso be an advantage if the device could only function when themonitoring functionality was active.

SUMMARY

The aim of the present disclosure is to remedy the drawbacks of thestate of the art medicament delivery devices in this area. This aim isobtained by a medicament delivery device having the features of theindependent patent claims. Preferable embodiments are found in thedependent patent claims.

The medicament delivery device as described herein may comprise ahousing, which housing is arranged to accommodate a medicamentcontainer. The medicament container may be arranged with a suitablemedicament delivery member that is capable of delivering a dose to auser. The medicament delivery member may be an injection needle, a mouthor nose piece or a nebulizer for inhaling the drug, etc. in order todeliver a dose, a drive unit may be operably arranged to act on themedicament container upon activation.

Further an activation mechanism may be operably arranged to be operatedby a user, as well as an activation preventing mechanism operablyarranged to prevent said activation mechanism to be activated. Therebythe activation preventing mechanism will not permit the delivery of adose until certain criteria are met.

A usage management module is preferably arranged to be operated by auser, wherein the usage management module may be designed as anattachable unit to the medicament delivery device. In that respect,first keying elements may be arranged on the medicament delivery deviceas well as on the usage management module. The keying elements aredesigned to interact with each other when attaching said usagemanagement module such as to cause a deactivation of the activationpreventing mechanism to allow operation of the activation mechanism.Thus, with the usage management module attached, the medicament deliverydevice may be used to deliver a dose of medicament to a user.

Further, the usage management module may preferably comprise amonitoring circuit arranged to monitor the use of the medicamentdelivery device. With this solution, an “add-on” monitoring circuit isprovided that is capable of monitoring the operation of the medicamentdelivery device during use, combined with an unlocking of the medicamentdelivery device. Thus, the suggested solution will ensure that a dosedelivery operation is monitored by the usage management module, sincethe medicament delivery device cannot be used without it. Further, theusage management module can be used for a large number of medicamentdelivery devices. In this respect, even low-tech, low-cost disposablemedicament delivery devices can be provided with monitoringfunctionality.

According to one favourable solution, the monitoring circuit may beactivated upon attachment of the usage management module with themedicament delivery device. In this way it is ensured on the one handthat the monitoring circuit is active when the device is to be used, andon the other hand, there is a reduced risk that the monitoring circuitis activated prematurely, which could lead to a drainage of power from apower source. In this respect, the activation of the monitoring circuitis preferably automatic, thus not requiring any user interaction, whichotherwise may lead to that the circuit is not active if the user hasforgotten to activate it.

According to one feasible solution, the monitoring circuit may beactivated upon a change of usage status of said medicament deliverydevice. The change of usage status may be different operations dependingon the type of medicament delivery device and the desired point ofactivation. For instance, the monitoring circuit may be activated when asafety cap is removed, when a dose of medicament is set, when the deviceis primed before injection, for example. One favourable change of usagestatus when the monitoring circuit could be activated is upon an end ofdose delivery operation. This has the advantage that it is ascertainedthat a dose delivery occurrence has been performed and monitored, i.e.that the patient is complying with the adherence scheme. If the deviceis activated before the dose delivery operation, it might be that forinstance the safety cap is removed but then the patient does not use thedevice. A change of status is then monitored but the patient has notcomplied with the treatment scheme.

The monitoring circuit may preferably be arranged with sensor elementscapable of monitoring and registering current status and status changesof the medicament delivery device upon use of the medicament deliverydevice. Status changes may for example be when a medicament containerhas been emptied and the there is an end of dose situation. This statuschange is a good registering point in that components inside themedicament delivery device that are moving during dose delivery come toa stop, which may be readily monitored.

In order to handle the registered status changes, the monitoring circuitmay comprise storage elements capable of storing registered data derivedduring the monitoring and registering. The stored data may then be usedlater for evaluation purposes of the usage of the medicament deliverydevice.

The usage management module may further comprise at least onecommunication circuit designed and arranged to communicate with externalcommunication elements. In this way, the monitored and registered datamay be communicated to appropriate devices adapted and arranged tohandle and evaluate the registered data. On the other hand, the externalcommunication elements may be elements arranged inside the medicamentdelivery device, which elements can detect status changes and transmitthe detected changes to the usage management module.

The communication circuits may comprise a number of differentcommunication technologies, either alone or in combination, comprisingnear range communication technology, wireless local area networkcommunication technology, digital cellular network communicationtechnology. In this respect the communication circuits are preferablyoperable to transmit registered data derived during the monitoring andregistering to external storage sources.

In addition to transmitting registered data from the usage managementmodule, the communication circuits may also be operable to receive datapertaining to the usage of the medicament delivery device. Thereby, theusage management module may then further comprise a communicationcircuit operable to communicate with a user of the medicament deliverydevice. In this manner, the user may receive information, such asadherence or compliance information, based on the monitored andregistered data that the usage management module has transmittedearlier.

Further information that might be valuable when evaluating the usage ofthe medicament delivery device may be the location of the user whenadministering a dose of medicament. Therefore, the usage managementmodule may further comprises a global positioning circuit, capable ofobtaining information regarding the actual position of the activatedmedicament delivery device and wherein the communication circuits aredesigned to transmit position information to external sources.

These and other aspects of, and advantages with, the present disclosurewill become apparent from the following detailed description of thedisclosure and from the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

In the following detailed description of the disclosure, reference willbe made to the accompanying drawings, of which

FIG. 1 is an exploded view of one embodiment of a medicament deliverydevice,

FIG. 2 is a cross-sectional side view of the device of FIG. 1,

FIGS. 3, 4 a, 4 b, 5, 6, 7, 8, 9, 10 and 11 are detailed views ofcomponents comprised in the device of FIG. 1,

FIGS. 12a and 12b comprise of exploded views of one feasible usagemanagement module according to the disclosure.

FIG. 13a is a perspective view of one embodiment where the end of a doseis registered and an electrically conductive material is in an openposition, and

FIG. 13b shows the embodiment of FIG. 13a where the electricallyconductive material is in a closed position.

DETAILED DESCRIPTION

In the following description, the wording medicament delivery devicewill be used. In this context, medicament delivery devices may include anumber of devices capable of delivering certain doses of medicament to auser, such as e.g. injection devices with or without injection needles,inhalers of all kinds, such as powder, aerosol driven, gas, nebulizershaving mouth or nasal pieces, dispensers for medicament in tablet form,eye dispensers, creme/gel dispensers, etc. The medicament deliverydevices may be of either disposable type or re-usable type and may beprovided with medicament containers suitably arranged for specific drugsin specific forms.

In the following description, the wording smart devices will be used. Inthis context, smart devices may include electronic devices that areprovided with processors that are capable of running computer programsas well as storage space to store programs as well as data retrievedfrom different external sources. It is further to be understood that thesmart devices are provided with communication systems that are capableof communicating with data networks in order to access differentdatabases. It is to be understood that databases may be accessed via theinternet, so called cloud services, and/or databases that are connecteddirectly to and accessed via local area networks. It is further to beunderstood that the smart devices in this context comprise some sort ofhuman-machine interface for two-way communication. The human-machineinterface may comprise displays, keyboards, microphones, loudspeakers,I/O-ports for connection of peripherals. Further the smart devices maybe provided with antennas for wireless communication with the networks.Also, the smart devices may be arranged with receiving and transmittingmechanisms capable of communicating with short range wirelesscommunication technologies like e.g. RFID, NFC or Bluetooth. The smartdevices are also arranged with programs capable of establishing andhandling the communication with RFID tags, NFC tags or Bluetoothcircuits.

Further, the term “distal part/end” refers to the part/end of thedevice, or the parts/ends of the members thereof, which under use of thedevice, is located the furthest away from a delivery site of a patient.Correspondingly, the term “proximal part/end” refers to the part/end ofthe device, or the parts/ends of the members thereof, which under use ofthe device is located closest to the delivery site of the patient.

The medicament delivery device shown in the drawings comprises agenerally tubular elongated housing 10 having a distal end 12 and aproximal end 14, FIG. 1. The housing 10 is further arranged with windowsor openings 16, through which a medicament container 18 can be viewed.The medicament container 18 is arranged with a movable stopper 20. Thedevice further comprises a medicament container holder 22 having agenerally tubular shape, FIG. 1. The medicament container holder 22 isarranged to accommodate the medicament container 18, where themedicament container 18 has a proximal end on which a medicamentdelivery member 24, FIG. 2, is arranged, either made integral orconnectable to the medicament container 18. The medicament deliverymember 24 is preferably protected before use by a medicament deliverymember shield 26 that in the embodiment shown is a so called rigidneedle shield or RNS. It is however to be understood that other types ofmedicament delivery member shields may be used in order to obtain thedesired protection of the medicament delivery member 24.

The proximal end of the housing is arranged with a central passage 28,FIG. 1, through which a generally tubular medicament delivery memberguard 30 extends. The medicament delivery member guard 30 is in thisembodiment an activation mechanism of the medicament delivery device. Itis arranged slidable in relation to the housing 10 such that the housing10 with the medicament container 18 and the medicament delivery member24 are moved in the proximal direction when the medicament deliverydevice is pressed against a dose delivery site, thereby exposing themedicament delivery member 24 such that a penetration is performed whenthe medicament delivery member is an injection needle.

The medicament delivery member shield comprises a proximal tubular 32part and two distally directed arms 34 extending from the tubular part32. A medicament delivery member guard spring 35 is arranged between adistally directed circumferential wall part of the medicament deliverymember guard 30 and a proximally directed circumferential surface of thehousing. The arms 34 are arranged slidable along the medicamentcontainer holder 22. At the distal end of the arms 34, inwardly directedprotrusions 36 are arranged. The protrusions 36 are arranged to operablyinteract with a rotator 38, FIG. 3, of a drive unit 40, when thedelivery member guard is moved in relation to the housing, wherein therotator 38 is positioned distally of the medicament container 18.

The rotator 38 has a generally tubular shape and is arranged with guideridges 42 that are intended to cooperate with the protrusions 36 of themedicament delivery member guard 30 as will be described, wherein somesections 42 _(i) of the guide ridges are inclined in relation to thelongitudinal axis L of the device.

An actuator 44, FIG. 3, is further arranged operably to the rotator 38.It comprises a first proximal tubular section 46 having a diameterslightly smaller than the inner diameter of the rotator 38. It furthercomprises a generally tubular second section 48 arranged to fit into andto be attached to a distal part of the housing. The second section 48 isprovided with a generally circular, radially extending, wall section 50.

The first section 46 is further arranged with proximally extending arms56 that are arranged flexible in a generally radial direction. The freeends of the arms 56 have outwardly extending protrusions 58 that are tointeract with inner surfaces of the rotator 38 as will be described.Further the free ends of the arms 56 are arranged with inwardlyextending protrusions 60, which protrusions 60 are intended to interactwith recesses 62 on a generally tubular plunger rod 64. The protrusions60 extend into a central passage 66 of the actuator 44, in which passage66 the plunger rod 64 fits.

The drive unit 40 further comprises a compression spring 68 placedinside a cavity of the hollow plunger rod 64, wherein the compressionspring 68 is positioned with a proximal end thereof in contact with anend wall 70 of the plunger rod 64, FIG. 2. The distal end of thecompression spring 68 is in contact with a generally U-shaped element,hereafter named activator 72, having a base 74 and two arms 76, FIG. 3.The arms 76 of the activator 72 are directed in the proximal directionalong, and in contact with, the outer surface of the plunger rod 64,wherein the free ends of the arms 76 are arranged with generallyradially outwardly directed ledges 78. These ledges 78 are arranged tobe in contact with a proximally directed surface 80 surrounding thecentral passage 66 of the actuator 44.

The medicament delivery device is further arranged with a protective cap82, FIG. 1, having a shape as to be releasably attached to the proximalend of the housing. The protective cap 82 is further arranged with amedicament delivery member shield remover 84 that in the embodimentshown has a generally tubular shape with a diameter so as to extend intothe medicament delivery member guard and surround the medicamentdelivery member shield 26. The medicament delivery member shield remover84 is arranged with grip elements 86 that are inwardly inclined,proximally directed tongues that are capable of gripping into thesurface of the medicament delivery member shield when the protective capis pulled in the proximal direction in relation to the medicamentdelivery device.

As mentioned above, the medicament delivery member guard 30 is movedinside and relative the housing 10 when the medicament delivery deviceis pressed against a dose delivery site. This in turn causes theprotrusions 36 of the medicament delivery member guard 30 to move alongthe guide ridges 42 of the rotator 38 such that the protrusions willcome in contact with the inclined sections 42 _(i), which will cause therotator 38 to turn around the longitudinal axis L of the device.

The turning of the rotator 38 will cause the arms 56 of the actuator 44to move out of contact with inner surfaces of the rotator 38. The arms56 of the actuator 44 are now free to flex outwardly, whereby theinwardly directed protrusions 60 of the arms 56 are moved out of contactwith the recesses 62 of the plunger rod 64.

The plunger rod 64 is now free to move in the proximal direction due tothe force of the compression spring 68, wherein the proximal end of theplunger rod 64 acts on, and moves, the stopper 20 inside the medicamentcontainer 18 in the proximal direction such that a dose of medicament isexpelled through the medicament delivery member 24.

The medicament delivery device is further arranged with an activationpreventing mechanism or a locking mechanism which is arranged to preventuse or activation of the medicament delivery device until the lockingmechanism is activated. The activation of the locking mechanism may beperformed in many ways that will be described below. According to onenon-limiting example of a locking mechanism it comprises an activationpreventing mechanism that in the embodiments shown is in the form of ablocking element 88, FIGS. 3 and 5. In the embodiment shown, theblocking element 88 is arranged with two semi-circular discs 90 _(I) and90 _(II), FIG. 3, oriented transversal to the longitudinal direction Land being adapted to fit around the second section 48 of the actuator44.

The blocking element 88 further comprises two proximally directed arms92 positioned radially outside the rotator. As seen in FIG. 4b , whereinthe device is in a non-activated state, the proximal ends of the arms 92of the blocking element 88 are in contact with the distal ends of thearms 34 of the medicament delivery member guard 30. Thus, the medicamentdelivery member guard 30 is locked from being moved in relation to thehousing 10 because the arms 34 of the medicament delivery member guard30 are abutting the arms 92 of the blocking element 88, therebypreventing activation of the device.

Further, the blocking element 88 may be held in the locking position bya locking element. In the embodiment shown the most distally orienteddisc 90 _(II) is arranged with the locking element that in theembodiment shown comprises a flexible arm 94 formed through a generallyU-shaped cut-out in the disc 90 _(II), FIG. 5. The free end of the arm94 is arranged with a distally directed protrusion 96, FIG. 5. Theprotrusion 92 is arranged and designed to fit into a passage 98, FIG. 3,in the wall section 50 of the actuator 44 when the locking element is inthe locking position, whereby the position of the protrusion 96 in thepassage 98 prevents any rotational movement of the blocking element 88.

Further, in the initial, locking position, a release element 100 isacting on the blocking element 88 with a force. In the embodiment shown,the release element 100 comprises a torsion spring 102, FIG. 5, shapedas an arch and attached to, or made integral with, a seat 104, whichseat 104 is arranged to be attached to the second section of theactivator. The seat 104 is arranged with a cut-out 106, in which agenerally radially extending protrusion 108 on the second section 48protrudes, FIG. 3, in order to lock the release element 100rotationally. In the initial locked position, the torsion spring 102 isin a tensioned state with its free end resting against a ledge 110 ofthe blocking element 88 as seen in FIG. 4 a.

In order to activate the medicament delivery device according to thedisclosure, the blocking element 88 of the locking mechanism has to beaffected such that the medicament delivery member guard 30 can be movedas described above. Further, the unlocking of the medicament deliverydevice should preferably activate a monitoring function such thatcurrent status and status changes of the device are monitored andregistered. This is important from a device usage point of view in thatthere is a monitoring of whether or not the users comply to prescribedtreatment schemes such as when a dose is taken, i.e. date and time. Itshould thus not be possible to use the device without the monitoringfunction being active, or at least it would be difficult to use thedevice alone.

In order to provide a monitoring function, which is connected to anunlocking operation of a medicament delivery device, a usage managementmodule is comprised in the present disclosure. The usage managementmodule 112 comprises a housing part 114 that is generally tubular, FIG.4, having generally the same diameter as the housing 10 of themedicament delivery device, as seen in FIG. 2. The usage managementmodule 112 is further arranged with keying elements that are arrangedand designed to cooperate with the medicament delivery device when theusage management module is attached. In this regard, it is to beunderstood that the usage management module may have a number of designsdepending on the desired appearance and for example the intended user.For instance, if the device is to be used by a child, the usagemanagement module may be designed as e.g. the head of mickey mouse orspiderman, to give a positive feel when the device is to be used.

In the embodiment shown in FIG. 4, the keying elements comprise acentral passage 116 with a proximally directed opening. The passage isarranged to fit onto a generally tubular distally directed post 118 ofthe medicament delivery device. Further, the central passage 116 isarranged with longitudinally extending grooves 120, two on oppositesides, whereby the post 118 is arranged with corresponding ridges 122that fit into the groves 120, providing a rotational lock of the usagemanagement module and a positioning aid. Further, the usage managementmodule is arranged with a proximally extending pin 124, FIG. 4b . Thepin 124 is positioned such that it will extend into the passage 98 whenthe usage management module 112 is attached to the distal end of themedicament delivery device.

The extending of the pin 124 into the passage 98 will cause its proximalend to come in contact with the protrusion 96 of the arm 94 and willpush the protrusion 96 out of the passage 98 against the bending forceof the arm 94 as seen in FIG. 6. The torsion spring 102 of the releaseelement 100 is now free to act on the blocking element 88 whereby itsforce on the ledge 110 will turn the blocking element 88 around thesecond section 48. The turning of the blocking element 88 will move thearms 92 of the blocking element 88 in a circumferential direction out ofthe locking position of the medicament delivery member guard, as seen inFIG. 6. The device may now be used as described above.

Another embodiment comprising keying elements is shown in FIGS. 7 and 8,where the usage management module 112 is arranged with keyingprotrusions 126, which keying protrusions are arranged on a proximallydirected surface 128 of the usage management module 112. These keyingprotrusions 126 have radially outwardly directed ledges 130 such as tofit into radially extending grooves 132, FIG. 7, on the distal surfaceof the wall section 50. The radially extending grooves 132 areinterconnected with generally arc-shaped grooves 134 on the wall 50section, and when the usage management module 112 is turned around thepost 118, the keying protrusions 126 will slide in the arc-shapedgrooves 134 with the ledges 130 in contact with a proximally directedsurface of the wall section 50, FIG. 9, thereby providing locking of theusage management module 112 in the longitudinal direction.

In this embodiment, the blocking element 88 is arranged with recesses136 on its distally directed end surface, FIG. 10, the position of whichcorresponds to the keying protrusions 126 when they are positioned intothe radially extending grooves 132 such that the keying protrusions 126extend into the recesses 136 of the blocking element 88. When now theusage management module 112 is turned around the longitudinal axis L ofthe medicament delivery device, then the blocking element 88 also isturned. This will in turn move the arms 92 of the blocking element 88out of contact with the arms 34 of the medicament delivery member guard30, FIG. 11, whereby the medicament delivery member guard 30 is free tobe moved as described above.

Also, as mentioned above, a monitoring function may preferably beactivated by the attachment of the usage management module or at leastwhen the medicament delivery device has been used, i.e. a status changehas occurred of the device. In this regard the usage management moduleis arranged with electronic circuitry 138, FIG. 12b , which couldcomprise a number of features and components such as processors, I/Ocircuits, memory circuits, just to mention a few. The description belowwill give more examples applicable for the present disclosure. Further,appropriate connectors 140, FIG. 12a , may be arranged to the I/Ocircuits. The usage management module is preferably arranged with anappropriate power source such as a button cell 142. In order to activatethe electronic circuitry of the usage management module and to “wake-up”the monitoring function, an appropriate switch is preferably arranged,operably connected to the circuitry.

The activation may be done at different stages upon handling of themedicament delivery device. As for the first embodiment, a switch mayfor example be arranged in connection with the pin of the usagemanagement module such that when the pin 124 comes in contact with theprotrusion 96 of the arm 94 and releases the blocking element 88, thepin 124 is also arranged to move a certain distance in the distaldirection, thereby closing a circuit inside a switch unit 144, FIG. 12b, leading to an activation of the device upon attachment of the usagemanagement module 112.

Another feasible solution regarding activation of the usage managementmodule 112 is to provide the proximally directed surface with twoelectrical contact points 146, 148, FIG. 4b , where one is connected tothe battery and the other to the circuitry 138. The distally directedsurface of the wall section 50 could then be arranged with an area 150having conductive material and positioned such that when the usagemanagement module 112 is attached to the medicament delivery device, thecontact points 146, 148 will both come in contact with the conductivearea 150, providing a contact between the contact points, whereby thecircuitry is powered up. This solution may also be used in connectionwith the second embodiment, where the turning of the usage managementmodule 112 may close the electrical circuit in that the two electricalcontact points 146, 148 and the conductive area 150 are positioned suchthat the contact points are moved into contact with the conductive areawhen the usage management module is turned into attachment position,whereby a current can flow from one contact point to the other contactpoint via the conductive area, which current will activate themonitoring function of the usage management module.

The monitoring function may comprise a number of actions and operationsthat the medicament delivery device performs. One basic action thatpreferably is monitored is the delivery of a dose of medicament.According to one feasible solution the end of dose delivery is monitoredand registered. In this respect, the switch that activates the usagemanagement module may be arranged to obtain information or data from themedicament delivery device. For example the circuitry 138 of the usagemanagement module 112 may be arranged with sensors that are capable ofregistering specific sounds or vibrations caused by components coming incontact with each other at the end of dose delivery, such aspiezo-electric components that are capable of picking up sounds, wherebythey will act as switches for the circuitry of the usage managementmodule.

Other designs of switches may incorporate electrical contacts positionedinside the medicament delivery device that are affected, opened/closed,when certain operations are performed in the medicament delivery device.For instance, when registering a dose delivery, a mechanical switchcomprising electrical contacts may be arranged between two movingcomponents, which switch is closed when the dose delivery sequence isended. FIG. 13 shows one such solution where the end of a dose isregistered. Near the end of a dose delivery when the plunger rod ismoving in the proximal direction, the activator 72 is released from itsattachment with the actuator 44. The activator 72 will then be moved inthe distal direction by the force of the drive spring 68 acting on thebase. The base will in turn act on a mechanical switch comprising atongue 152 of electrically conductive material such that the tongue 152will move from an open position as seen in FIG. 13a , to a closedposition as seen in FIG. 13b , where the tongue 152 is moved in contactwith a contact surface 154 and the switch is closed.

For this solution, appropriate conduits are provided inside themedicament delivery device, and an appropriate interface is providedbetween the proximal surface of the usage management module and thedistal directed surface of the wall section, thereby providing anelectrical contact between the medicament delivery device and the usagemanagement module when attached. The interface could in a simple form beelectrical contacts 158, FIG. 7, on the distally directed surface of thewall section 50 that connect to corresponding electrical contacts 160,FIG. 8, on the proximal surface of the usage management module 112 whenattached.

In this respect, it is to be understood that other components may bearranged with switching or activation functionality in order to activatethe usage management module but also for monitoring purposes. Forinstance, sensors may be arranged to identify that the protective caphas been removed earlier, and being put back again, which has adverselyaffected the sterility of the medicament delivery member. Thisinformation is transmitted to and stored in the usage management module.The information may then be retrieved from the usage management moduleby for example attaching an appropriate cable that has a connectorcorresponding to the connector of the usage management module. The otherend of the cable may then be connected to a computer or a smart devicefor handling and processing of the information. It is also to beunderstood that certain switches and sensors may be arranged inside theusage management module in order to obtain switching or activationfunctionality.

In the above scenario, the usage management module may comprise a usercommunication circuit that is arranged and programmed to communicatewith a user. The user communication circuit may comprise displayelements that can communicate visually, e.g. by text stored in theelectronics module that is displayed on a suitable display on thedevice. In addition to, or instead, the user communication circuit maycomprise audio elements that can communicate audibly, e.g. by a recordedmessage stored in the electronics module that is played in anappropriate loudspeaker of the electronics module or of the device assuch.

A further development of the activation function is to provide the usagemanagement module with at least one communication circuit and to providethe medicament delivery device with data storage or data informationproviding elements. These communication technologies may comprise nearrange communication technology such as RFID, NFC or the like, as well asBluetooth, Ant, Zigbee, just to mention a few. This type of wirelesscommunication technology may then be used to activate the usagemanagement module. For instance, the medicament delivery device may bearranged with a passive NFC-tag that could be comprised in a labelattached to the medicament delivery device or embedded in the materialof the medicament delivery device. The communication circuits of theusage management module are then capable of reading the NFC-tag whenadjacent the medicament delivery device, whereby the usage managementmodule is activated for monitoring. Also, the communication circuit maybe used for monitoring the usage of the medicament delivery device suchthat information is transmitted from the medicament delivery device tothe usage management module. For instance, a switch may be affected atthe end of a dose operation, which may be detected by the NFC andtransmitted to the usage management module.

In this regard, the NFC-technology may be used to register and deriveadditional information from the medicament delivery device. Forinstance, the medicament container may be provided with an NFC-tag thatcan be read by the NFC-circuit of the usage management module. Theobtained information may then be stored in the usage management moduleand/or compared to pre-stored information. The information may comprisethe type of drug that should be administered according to a treatmentscheme, wherein the usage management module will authenticate thecorrect drug.

Regarding monitoring and registering of the status of the device as wellas status changes, such as e.g. end of dose delivery sequence, thecircuitry of the usage management module preferably is arranged with atimer function, by which it is possible to derive when a certain statuschange has occurred. There are many different techniques for providingthis information, where on the one hand a program may be provided forthe processor of the circuitry to handle date and time of occurrencesand to store this information in the storage elements. This informationmay then be obtained by external sources when e.g. connecting the usagemanagement module via its I/O-elements. On the other hand, the circuitrymay instead be arranged with a counter that starts at the registeredstatus change and when the usage management module is connected to anexternal source, the external source is capable of deriving the date andtime of the occurrence by counting backwards the time the timer hascounted from current time.

According to another possible feature, if the usage management module isprovided with communication circuits, then monitoring data obtained bythe usage management module may be transferred to external storagesources and/or external devices. If for instance NFC technology is used,then a mobile device being NFC-enabled may derive the monitored datafrom the usage management module. The mobile device may then either becapable of handling the data, such as e.g. calculating the time and dateof an occurrence of the medicament delivery device, or may in turntransmit the monitored data to external databases via the communicationtechnologies of the mobile device, such as cellular radio communicationnetworks, e.g. GSM, 3G, 4G, etc. and/or wireless local area networks,which networks can provide access to the internet and thus to a largenumber of external data storage sources, data handling centres, etc.

Regarding communication technologies, it is of course possible toincorporate the above mentioned communication technologies in the usagemanagement module as such. Then the usage management module maycommunicate directly with external data storage sources, data handlingcentres etc. via the communication networks. The monitoring data maypreferably be accessible to a physician or the like skilled person thatis responsible for the treatment of the user of the medicament deliverydevice and who might have put together a treatment scheme. Thisretrieved monitoring data may then be evaluated to derive informationsuch as adherence, and the lack of which may lead to measures from thephysician. These measures may be that information is transmitted back tothe usage management module via the communication circuits, whichinformation retrieved by the usage management module may be communicatedto the user via the user communication circuit, and in particular if theuser has deviated from the prescribed treatment scheme. The user may inthat respect also be informed what measures that need to be taken inorder to remedy the deviation. The usage management module may furtherbe arranged with a circuit that is arranged to transmit a signal or ashort data message at periodic intervals to an external data informationhandling centre that preferably is the same as for the monitoring data.

The signal is sent periodically, providing information that the usagemanagement module is functioning. If such periodic signals are receivedbut no monitoring data is received, this is a clear indication that theuser does not use the device as prescribed, i.e. non-adherence. Withouta periodic signal, if no monitoring data is received, there would be anuncertainty whether the usage management module is functioning or not,i.e. that the power source of the usage management module may bedepleted for instance or that it is a sign of non-adherence.

The usage management module may be arranged with further registeringcapabilities that may be activated for instance when a dose isdelivered, which is monitored and registered by the usage managementmodule. The electronic circuits may be arranged with a positioningfunction whereby the geographical position of the user may be obtainedand used for different purposes. In this respect, the positioning may beobtained by different functions. Either the electronics module isprovided with a GPS-function, whereby the actual position of the userwhen the dose is delivered is recorded by GPS coordinates. Anotherpossibility is to use the GSM-function for locating the position. TheGPS-function and the GSM-function may further be combined with a WIFIlocation function for improved indoors location.

Regarding the activation of the usage management module, the circuitrycould preferably be arranged with a suitable switch-off functionality,such as a timer function that will switch off the power to the circuitryafter a certain time period for instance after completed medicamentdelivery operation. This will prolong the life of the power source inthat it is not active when no action is taking place.

In the above examples of preventing activation or blocking of themedicament delivery device, a medicament delivery member guard isblocked until activation. It is however to be understood that otheractivation mechanisms and thus elements of the medicament deliverydevice may be blocked, depending on the actual design of the device. Forinstance, an activation button may be blocked, a drive unit, such as apiston rod may be blocked or activation components are positioned out ofcontact with each other until the usage management module is attached.

It is to be understood that the embodiments described above and shown inthe drawings are to be regarded only as non-limiting examples of thedisclosure and that it may be modified in many ways within the scope ofthe patent claims.

1. A medicament delivery device comprising a housing constructed toaccommodate a medicament container; a drive unit configured to operablyact on the medicament container upon activation; an activation mechanismconfigured for operation by a user; an activation preventing mechanismoperably configured that prevents a user from activating the activationmechanism; a usage management module configured for operation by a user,where the usage management module is attachable to the medicamentdelivery device; and first keying elements arranged on the medicamentdelivery device and on the usage management module that interact witheach other when the usage management module is attached to themedicament delivery device, where the attachment causes deactivation ofthe activation preventing mechanism and allowing operation of theactivation mechanism, where the usage management module comprises amonitoring circuit that monitors the use of the medicament deliverydevice.
 2. The medicament delivery device of claim 1, where themonitoring circuit is immediately activated when the usage managementmodule is connected to the medicament delivery device.
 3. The medicamentdelivery device of claim 1, where the usage management module furthercomprises at least one communication circuit designed and arranged tocommunicate with external communication elements.
 4. The medicamentdelivery device of claim 3, where the usage management module furthercomprises a global positioning circuit that communicates the position ofthe activated medicament delivery device to communication circuits thattransmit the position information to external sources.
 5. The medicamentdelivery device of claim 3, where the usage management module furthercomprises electrical contacts that align and contact correspondingelectrical contacts on the medicament delivery device when the usagemanagement element is attached to medicament delivery device.
 6. Themedicament delivery device of claim 3, where the first keying elementson the medicament delivery device are radially extending grooves.
 7. Themedicament delivery device of claim 6 where the first keying elements onthe usage management module are axially extending protrusions that fitinto the radially extending grooves when the usage management module isattached to the medicament delivery device such that relative movementof the first keying elements forms a locking connection.